Non-invasive breathing assistance apparatus and method

ABSTRACT

An nCPAP device for assisting patient breathing includes a generator body forming an inlet, a chamber, and first and second flow circuits. The chamber directs pressurized gas from the inlet to the flow circuits. The flow circuits each include a nozzle, a channel, and at least one port. The nozzle emits a jet stream into the channel in a direction of a patient side thereof. The port fluidly connects the channel to ambient, and promotes entrainment of ambient air with the jet stream. In some embodiments, the channel forms a ramp feature directing exhaled air toward the jet stream in an angular fashion. The generator body requires reduced driving pressures to achieve target CPAP levels and reduces total imposed WOB as compared to conventional designs.

BACKGROUND

The present disclosure generally relates to devices and methods forgenerating and delivering continuous positive airway pressure therapy orother non-invasive breathing assistance to patients, such as infants.More particularly, the present disclosure relates to variable flow,nasal continuous positive airway pressure systems, devices, and methodswith reduced driving pressure requirements and improvedwork-of-breathing.

Continuous positive airway pressure (CPAP) therapy has been employed formany years to treat patients experiencing respiratory difficultiesand/or insufficiencies. In addition, CPAP therapy can beneficiallyassist patients with under-developed lungs (in particular, infants andespecially premature infants or neonates) by preventing lung collapseduring exhalation and assisting lung expansion during inhalation.

In general terms, CPAP therapy entails the continuous transmission ofpositive pressure into the lungs of a spontaneously breathing patientthroughout the respiratory cycle. CPAP can be delivered to the patientusing a variety of patient interface devices, for example anendotracheal tube or nasal cannula. With infants, however, it is moredesirable to employ a non-invasive patient interface device, inparticular one that interfaces directly or indirectly with the nasalairways via the patient's nares. Such systems are commonly referred asnasal continuous positive airway pressure (nCPAP) systems.

In theory, the CPAP system should deliver a constant, stable pressure(above atmospheric pressure) to the patient's airways. With conventionalCPAP systems, a relatively constant and continuous flow of gas (e.g.,air, oxygen, etc.) is delivered into the patient's airways, with thisairflow creating a pressure within the patient's lungs via a restrictionplaced on outflow from the patient. Unfortunately, this continuous flowcan have an adverse effect on the patient's respiratory synchrony. Moreparticularly, the patient is required to exhale against the incominggas, thus increasing the patient's work-of-breathing. Control valves canbe employed to better accommodate inspiratory and expiratory stages of apatient's breathing cycle (e.g., controlling gas flow into the systemand/or altering an extent of restriction from outflow from the system).However, for many patients, especially infants, this approach is lessthan satisfactory as the patient's required work-of-breathing is quitehigh. That is to say, it is essentially impossible for a control valvesystem to accurately replicate the actual respiratory cycles experiencedby the patient, such that the patient will consistently be required toexhale against the momentum of the incoming gas, as well as against theresistance of the control valve(s). For an infant with underdevelopedlungs, even a slight increase in the required work-of-breathing mayrender the CPAP system in question impractical.

More recently, nCPAP systems have been developed that incorporate avariable flow concept in combination with separate channels forinspiratory and expiratory gas to and from the patient. When the patientinhales, the incoming gas takes the path of least resistance and isdirected to the patient's airways. Upon expiration, the gas again takesthe path of least resistance and goes out an exhaust port, thus reducingresistance during the expiratory phase of breathing. For example, theInfant Flow™ system, available from CareFusion, Inc., of San Diego,Calif., includes a variable flow CPAP generating device (or “CPAPgenerator”) that causes the direction of the supply gas to change withthe infant's breathing patterns while maintaining a nearly constantpressure throughout the respiratory cycle. The Infant Flow CPAPgenerator converts supplied gas into jet streams (one for each naris),with the momentum of the gas jet creating a positive pressure inside thepatient's lungs, in accordance with known physics principles. Toaccommodate expiratory flow from the patient, the Infant Flow CPAPgenerator relies upon what the manufacturer's literature lists as a“fluidic flip” effect. The expiratory airflow from the patient applies apressure onto the incoming jet steam flow. It has been theorized thatdue to the Coanda effect, the expiratory airflow causes the jet streamflow to deflect, thus triggering a fluidic flip of the incoming jetflow. As a result, the jet stream and the expiratory airflow readilyproceed to the exhaust port, thus reducing the patient's requiredwork-of-breathing. While quite promising, the jet streams generated insuch devices have a relatively high momentum that may not be easilyovercome by the patient's expiratory breathing, especially with infants.Moreover, driving gas pressure levels that must be applied to these andother commercially available variable-flow CPAP generators to producetherapeutic CPAP levels are not sufficiently low to permit usage with acommon ventilator. Instead, a dedicated high-pressure flow driver isrequired.

In light of the above, needs exist for improved nCPAP systems, devices,and methods.

SUMMARY

Some aspects in accordance with principles of the present disclosurerelate to a nasal continuous positive airway pressure (nCPAP) device forassisting patient breathing. The device includes a generator bodyforming an inlet, a chamber, and first and second flow circuits. Theinlet is configured for fluid connection to a source of pressurized gas.The chamber is fluidly connected to the inlet. The first and second flowcircuits are fluidly connected to the chamber and each include a nozzle,a channel, and an open port. The nozzle defines an inlet end and anoutlet end, with the inlet end being fluidly connected to the chamber.The outlet end is opposite the inlet end, has a diameter less than thediameter of the inlet end, and is adapted to emit a gas jet stream intothe channel. The channel has or defines a nozzle side fluidly connectedto the outlet end of the nozzle, and a naris or patient side oppositethe nozzle side for interfacing with a patient's naris. Each of thechannels forms a ramp feature having an inclined region extending from alocation of the open port in a direction of the patient side, and adeclined region extending from the inclined region toward the patientside. In some embodiments, the ramp feature promotes jet stream flowpatterns that rapidly switch from inside the channel to the open port.For example, the declined region facilitates diversion of the jet streamby exhaled airflow during the expiratory phase of operation, and theinclined region optionally facilitates return of the jet stream into thechannel during the inspiratory phase of operation. The port is open toambient, and is fluidly connected to the channel at a location betweenthe nozzle side and the patient side. During use, pressurized gasdelivered to the chamber via the inlet is converted to a fixed flow jetstream by the nozzles, creating CPAP in each of the channels. Further,the generator body establishes an inspiratory flow pattern during aninspiratory stage of breathing and an expiratory flow pattern during anexpiratory stage of breathing. With the expiratory flow pattern, exhaledair from the patient side of each of the channels is directed by theramp feature to cause at least a portion of the jet stream flow todivert to, and exhaust from, the corresponding port. The generatorbodies of the present disclosure require reduced inlet or drivingpressures to achieve desired therapeutic CPAP levels and/or reduce totalimposed work-of-breathing by the patient.

Other aspects in accordance with principles of the present disclosurerelate to a nasal continuous positive airway pressure (nCPAP) systemincluding a generator body, a patient interface piece, and a source ofgas. The generator body defines an inlet, a chamber, and first andsecond flow circuits. The chamber is fluidly connected to the inlet, andthe flow circuits are fluidly connected to the chamber. Each of the flowcircuits includes a nozzle, a channel, and a port. The nozzle creates ajet stream from pressurized gas in the chamber, and directs the jetstream into a nozzle side of the channel. The port is open to ambientand is fluidly connected to the channel at a location between the nozzleside and an opposite, patient side of the channel. The patient interfaceincludes first and second prongs fluidly connected to the patient sideof the channels, respectively, and is configured for fluid connection toa patient's nares. Finally, the source of gas is fluidly connected tothe inlet of the generator body and provides a continuous flow ofpressurized gas. Upon connection of the interface piece to the patient'snares and of the source of gas to the inlet, a fixed amount of jetstream flow is established in each of the channels by the correspondingnozzle. Momentum of the jet streams deliver CPAP to the patient. In aninspiratory phase of operation, ambient air is, where necessary,entrained into the jet stream flow delivered to the patient's nares viathe corresponding ports. In an expiratory phase, exhaled air from thepatient nares diverts the jet stream flow from the nozzle and isexhausted through the corresponding ports. In some embodiments, thesystem is configured to provide a CPAP level of 5 cm H₂O and totalimposed work-of-breathing of not greater than 140 mJ/L for a 9 mL tidalvolume patient under conditions where the source of gas is delivering adriving pressure of not more than 25 cm H₂O. At these lower pressureoperating conditions, the source of gas can be a common ventilator.

Yet other aspects in accordance with principles of the presentdisclosure relate to a method for establishing and delivering acontinuous positive airway pressure to a patient. The method includesfluidly connecting a generator body to nares of the patient. Thegenerator body forms first and second flow circuits each including anozzle, a channel, and a port. The channel includes first and secondramp regions. The port fluidly connects the channel with ambient air ata location between an outlet end of the nozzle and a patient side of thechannel. Gas from a source of pressurized gas is forced at a drivingpressure to an inlet end of each of the nozzles. A jet stream from eachof the nozzles is directed toward the patient's nares via the channel toestablish a continuous positive airway pressure in the patient's airway.During periods of patient exhalation, exhaled air from is directed bythe second ramp region to divert the jet stream to the port at which thejet stream is exhausted from the generator body. In some embodiments,the driving pressure is not greater than 110 cm H₂O and the establishedcontinuous positive airway pressure level is 20 cm H₂O. In some otherembodiments, the driving pressure is not greater than 25 cm H₂O, theestablished continuous positive airway pressure is 5 cm H₂O, and a totalimposed work-of-breathing for a 24 mL tidal volume patient during theperiods of inhalation and exhalation is not greater than 200 mJ/L.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram illustrating one embodiment of a nasalcontinuous positive airway pressure system including an nCPAP device inaccordance with principles of the present disclosure;

FIG. 2A is a perspective view of a generator body in accordance withprinciples of the present disclosure and useful with the nCPAP device ofFIG. 1;

FIG. 2B is a perspective cross-sectional view of the generator body ofFIG. 2A;

FIG. 2C is a longitudinal cross-sectional view of the generator body ofFIG. 2A;

FIG. 3 is a perspective modeling of an internal fluid volume of thegenerator body of FIG. 2A;

FIG. 4A is a cross-sectional view of the generator body of FIG. 2A andillustrating fluid flow during an inspiratory phase of operation;

FIG. 4B is a cross-sectional view of the generator body of FIG. 2A andillustrating fluid flow during an expiratory phase of operation;

FIG. 5 is a perspective view of a patient interface piece useful withthe system of FIG. 1;

FIG. 6A is a perspective view of another generator body in accordancewith principles of the present disclosure and useful with the nCPAPdevice of FIG. 1;

FIG. 6B is a perspective cross-sectional view of the generator body ofFIG. 6A;

FIG. 7 is a longitudinal cross-sectional view of another generator bodyin accordance with principles of the present disclosure;

FIG. 8A is a cross-sectional view of the generator body of FIG. 7 andillustrating formation of a jet stream during use;

FIG. 8B is a cross-sectional view of the generator body of FIG. 7 andillustrating fluid flow during an inspiratory phase of operation;

FIG. 8C is a cross-sectional view of the generator body of FIG. 7 andillustrating fluid flow during an expiratory phase of operation;

FIG. 9 is a perspective modeling of an internal fluid volume of thegenerator body of FIG. 7;

FIG. 10 is a graph of experimental test results comparing drivingpressure requirements of generator bodies of the present disclosure withthose of currently available nCPAP generator products; and

FIG. 11 is a graph of experimental test results comparing the totalimposed work-of-breathing requirements of the generator bodies of thepresent disclosure with those of currently available nCPAP generatorproducts.

DETAILED DESCRIPTION

One embodiment of a nasal continuous positive airway pressure (nCPAP)system 20 incorporating an nCPAP device 22 in accordance with principlesof the present disclosure is shown in block form in FIG. 1. In generalterms, the system 20 is adapted to provide CPAP therapy to a patient 24,and includes the nCPAP device 22 and a source of pressurized gas 26. ThenCPAP system 20 can further optionally include a pressure monitor 28.The nCPAP device 22 is described in greater detail below, and generallyincludes a generator body 30 and a patient interface piece 32.Optionally, ambient air tubing 34 can also be provided. The generatorbody 30 is fluidly connected to the patient interface 32 and theoptional ambient air tubing 34, with the patient interface piece 32being adapted to establish fluid communication with the patient's 24nasal airways. The source of pressurized gas 26 provides the generatorbody 30 with a continuous flow of gas (e.g., air and/or oxygen). Whereprovided, the pressure monitor 28 is also fluidly connected to thegenerator body 30 and samples or measures pressure therein. During use,the generator body 30 acts upon gas from the source 26 to generate anddeliver a continuous positive airway pressure to the patient 24 via thepatient interface piece 32. As the patient 24 exhales, the exhaled airreadily flows through the patient interface piece 32/generator body 30,and is exhausted from the nCPAP device 22 as described below.

One embodiment of the generator body 30 in accordance with principles ofthe present disclosure is shown in FIGS. 2A and 2B. In general terms,the generator body 30 is configured to establish CPAP for inspiratoryand expiratory flow of gas to and from the patient 24 (FIG. 1). Withthis in mind, the generator body 30 forms or defines a supply gas inlet40, a chamber 42 (shown in FIG. 2B), and first and second flow circuits44 a, 44 b (referenced generally in FIG. 2A; the first flow circuit 44 abeing shown in greater detail in FIG. 2B). In general terms, the inlet40 is configured for fluid connection to the source of pressurized gas26 (FIG. 1), and directs incoming gas into the chamber 42. The flowcircuits 44 a, 44 b are fluidly connected to the chamber 42. Thus, gasflow provided at the inlet 40 is directed through the chamber 42 andthen toward the patient via the flow circuits 44 a, 44 b. In thisregard, and as described in greater detail below, the flow circuits 44a, 44 b incorporate one or more features that promote exhausting ofsupplied gas and exhaled air during inspiratory and expiratory phases ofoperation with minimal patient work-of-breathing effort. The generatorbody 30 can incorporate additional, optional components, such as apressure monitoring port 48, an exterior flange 50, etc.

In some embodiments, the generator body 30 can have a two (or more)piece construction, including a supply section 60 and a circuit section62. The sections 60, 62 can be separately formed (e.g., molded plastic)and assembled to another, with the supply section 60 forming the inlet40 and the chamber 42. The circuit section 62 forms the flow circuits 44a, 44 b. Alternatively, other constructions are also envisioned, such asintegrally constructing the generator body 30 as a single, homogenousbody.

The inlet 40 can assume various forms (e.g., size and shape) appropriatefor fluid connection to a supply tube (not shown) extending from thesource of gas 26 (FIG. 1). As best shown in FIG. 2B, the chamber 42 isfluidly connected to the supply inlet 40 and is fluidly open to thefirst and second flow circuits 44 a, 44 b, with FIG. 2B illustratingfluid communication between the chamber 42 and the first flow circuit 44a. Effectively, then, an internal wall 64 (referenced generally in FIG.2B) provides or forms a manifold that is fluidly open to the chamber 42and the flow circuits 44 a, 44 b.

The first and second flow circuits 44 a, 44 b are, in some embodiments,identical such that the following description of the first flow circuit44 a is equally applicable to the second flow circuit 44 b. The firstflow circuit 44 a includes or defines a nozzle 70, a channel 72, and atleast one open port 74. The nozzle 70 is fluidly open to the channel 72,as is the open port(s) 74. As described in greater detail below, then,gas flow from the nozzle 70 is forced into the channel 72 in a directionof a naris or patient side 76 of the channel 72. During patientinhalation, ambient air can be entrained into the delivered gas flowand/or excess gas exhausted via the port 74 depending upon the patient'sinspiratory requirements. Conversely, exhaled air from the patient atthe patient side 76 can be exhausted through the open port(s) 74, as candiverted jet stream flow from the nozzle 70.

The nozzle 70 can assume various forms, and generally includes ordefines an inlet end 80 and an outlet end 82. The inlet end 80 isfluidly connected to the chamber 42. The outlet end 82 is opposite theinlet end 80, and is positioned to direct gas flow into the channel 72.The outlet end 82 has a reduced diameter as compared to the inlet end80. With this construction, pressurized gas in the chamber 42 (via theinlet 40) is forced to the nozzle 70, that in turn converts the gas flowinto a low momentum jet stream directed into the channel 72. Theso-generated jet stream is described in greater detail below. Generally,however, the jet stream acts within the channel 72, generally directedtoward the patient side 76 (and thus the patient) to create a continuouspositive airway pressure (e.g., the jet stream momentum is convertedinto pressure).

The channel 72 is generally defined by a tube-like body 90 extendingfrom the patient side 76 to a nozzle side 92 that is fluidly connectedto the outlet end 82 of the nozzle 70. The open port 74 is formedthrough a thickness of a wall of the tubular body 90, and thus isfluidly open to the channel 72. A geometry of the channel 72 inextension from the open port 74 to the patient side 76 establishesdesired gas flow patterns during the inspiratory and expiratory phasesof operation as described below.

In particular, relative to the cross-sectional view of FIG. 2C, thechannel 72 can be described as having or being defined by an upper wallsurface 100 and a lower wall surface 102. The open port 74 is fluidlyopen to the channel 72 at the upper wall surface 100. The lower wallsurface 102 is defined opposite the upper wall surface 100 and includesfirst and second ramp regions 110, 112. The first ramp region 110extends from a port location 114 (otherwise aligned with the open port74) to a transition location or peak 116 that is longitudinallydisplaced from the open port 74 in a direction of the patient side 76.As a point of reference, the channel 72 can have an increased orelevated diameter at the port location 114, for example by forming anangled guide surface 118 at the nozzle side 92 (e.g., the angled guidesurface 118 can be arranged at an angle on the order of 40 degree fromvertical in some embodiments). Regardless, the first ramp region 110 hasan inclined or ascending orientation relative to the upper wall surface100 in extension from the port location 114 to the transition location116. Stated otherwise, a linear distance between a plane (relative tothe longitudinal cross-sectional view of FIG. 2C) of the upper wallsurface 100 and the lower wall surface 102 at the port location 114 isgreater than a linear distance between the upper wall surface 100 andthe lower wall surface 102 at the transition location 116.

The second ramp region 112 extends from the transition location 116 toor toward the patient side 76. For example, the second ramp region 112can be characterized as terminating at an intermediate location 120 thatis spatially between the patient side 76 and the transition location116. The second ramp region 112 has a declined or descending arrangementrelative to the upper wall surface 100 in extension from the transitionlocation 116 to the intermediate location 120. Stated otherwise, alinear distance between the upper wall surface 100 and the lower wallsurface 102 at the transition location 116 is less than a lineardistance between the upper wall surface 100 and the lower wall surface102 at the intermediate location 120. In some embodiments, thedescending orientation or arrangement of the second ramp region 112 cancontinue to the patient side 76. With the one embodiment of FIG. 2C,however, the channel 72 has a relatively uniform diameter in extensionfrom the intermediate location 120 to the patient side 76.

A slope of the first ramp region 110 can be less than a slope of thesecond ramp region 112 as shown. Alternatively, other sloperelationships are also envisioned. Regardless, the ramp regions 110, 112serve as flow directors relative to gas flow to and from the patientside 76 as described below.

The open port 74 is open to the channel 72 at an interior aperture 120in the upper wall surface 100, and is open to ambient at an exterioraperture 122. The port 74 can have an expanding cross-sectional area inextension from the interior aperture 120 to the exterior aperture 122.In some embodiments, and as reflected by the internal fluid volume modelof the generator body of FIG. 3, opposing side walls 124 (theoreticallyrepresented in FIG. 3) of the port 74 can have an angular extension tothe exterior aperture 122, further contributing to the expandingcross-sectional area construction of the port 74. Regardless, the openport 74 can be referred to as an ambient port, serving to fluidlyconnect the channel 72 with ambient air/pressure. It will be understood,however, that an intermediate body or device (e.g., exhaust tubing,return line, etc.), can be assembled to the open port 74 in establishingan ambient-type connection. While the generator body 30 is shown asincluding the single port 74 with each of the flow circuits 44, in otherembodiments, one or more secondary ports can be provided as describedbelow.

During operation, pressurized gas (e.g., from the source of gas 26 (FIG.1)) is provided to the chamber 42 via the supply inlet 40. The suppliedgas is forced into the flow circuits 44. As shown for the first flowcircuit 44 a in FIG. 4A, the nozzle 70 converts the gas flow to a jetstream N that is directed into the channel 72. As a point of reference,FIG. 4A illustrates the generator body 30 during an inspiratory stage ofoperation. Pressurized gas is delivered to the chamber 42 via the supplyinlet 40 and is directed toward the flow circuits 44. With respect tothe first flow circuit 44 a shown, the nozzle 70 converts the deliveredgas into a jet stream (represented by arrows N in FIG. 4A) that isdirected to the channel 72. The jet stream N establishes a continuouspositive airway pressure within the channel 72 (i.e., the jet stream Nmomentum is converted into pressure) that is applied to the patient side76, and thus the patient. At least a portion of the jet stream N flow isdirected through the channel 72 and delivered to/inhaled by the patientat the patient side 76. Depending upon the patient's inspiratoryrequirements, ambient air (represented by arrows A in FIG. 4A) can beentrained into the delivered jet stream N via the open port 74.Similarly, and as a function of the patient's respiratory needs, aportion of the jet stream N experiences a recirculating flow R adjacentthe open port 74 as well as along the second ramp region 112. Theserecirculating flows R, in turn, divert an excess portion (represented byarrow E in FIG. 4A) of the jet stream N and/or entrained air A to theopen port 74 as exhaust flow. Thus, when the jet stream N flow exceedsthe inspiratory demand of the patient, excess gas is exhausted via theport 74.

During the expiratory phase of operation shown in FIG. 4B, the jetstream N continues to be generated by and emitted from the nozzle 70into the channel 72, maintaining the continuous positive airway pressuredelivered to the patient due to the jet stream's momentum. Exhaled air(represented by arrows X in FIG. 4B) enters the channel 72 at thepatient side 76, and acts upon the jet stream N flow. In this regard,relative to a flow direction of the exhaled air X, the second rampregion 112 defines a tapering hydraulic diameter that increases themagnitude of the velocity of the exhaled air X at the transitionlocation or peak 116. Further, the second ramp region 112 effectively“focuses” a portion of the exhaled air X “upwardly” toward the jetstream N flow. This focused, upward flow diverts or “turns” the jetstream N (and any entrained ambient air A) toward the open port 74.Also, a recirculating flow (represented by arrow R in FIG. 4B) is formedbetween the jet stream N and the exhaled air X adjacent the upper wallsurface 100 in a zone of the first ramp region 110 that enhancesdiversion of the jet stream N toward the open port 74. The jet stream N,as well as a substantial portion of the exhaled air X and any ambientair A, exhausts from the generator body 30 via the open port 74. Thus,the open port 74 the ramp regions 110, 112, and a geometry of the jetstream N combine to establish flow patterns that minimize resistance tothe exhaled air X and patient effort required to draw the jet stream Nback into the channel 72 upon inspiration. This results in low patientwork-of-breathing during both inspiratory and expiratory operation.

It has surprisingly been found that the ramp features described above incombination with one or more geometry characteristics render thegenerator body 30 capable of establishing desired CPAP levels at lowdriving pressures and with minimal patient work-of-breathing. Forexample, in some embodiments, the nozzle outlet end 82 has a diameter(and thus a diameter of the resultant jet stream N) on the order of0.04-0.07 inch, optionally 0.058 inch. A diameter (or height) of thechannel 72 at the patient side 76 is on the order of 0.10-0.16 inch,optionally 0.136 inch. With these and other geometry considerations, thegenerator body 30 optionally establishes a ratio of channel height (atthe patient side 76) to jet diameter in the range of 2.29-2.50,optionally 2.34. An angle of incline (relative to horizontal) along thefirst ramp region 110 is in the range of 5°-10°, optionally 7.1°; anangle of decline (relative to horizontal) along the second ramp region112 is in the range of 12°-19°, optionally 16.5°.

Returning to FIGS. 2A and 2B, the optional pressure monitoring port 48is located to tap or sample air pressure within the generator body 30.The pressure monitoring port 48 can be fluidly connected to one or bothof the flow circuits 44 a, 44 b, and provides a surface appropriate forconnection to monitoring tubing (not shown) extending to the pressuremonitor 28 (FIG. 1). In other embodiments, the pressure monitoring port48 can be omitted.

The optional exterior flange 50 surrounds the tube bodies 90, and servesto direct or deflect exhausted airflow away from the patient. In otherembodiments, the exterior flange 50 provides a surface for mounting ofvarious other components, such as the patient interface 32 describedbelow. In other embodiments, the flange 50 can be omitted.

As best shown in FIGS. 2A and 2B, the generator body 30 can incorporateadditional features facilitating connection with other components of thenCPAP system 20 (FIG. 1) and/or desired functioning. For example, thetube bodies 90 associated with the flow circuits 44 a, 44 b can form ordefine an exterior taper 140 adapted to promote a secured, sealedattachment with the patient interface piece 32 (FIG. 1), along withradial slots 142 that provide a region from which pressure otherwisepresent in the corresponding channel 72 can be tapped or sampled.

Returning to FIG. 1, the patient interface 32 useful with the generatorbodies of the present disclosure can assume various forms. For example,FIG. 5 generally illustrates one exemplary embodiment of the patientinterface piece 32 that includes a pair of nasal prongs 150 a, 150 bprojecting from a base 152. The base 152 can incorporate additionalfeatures, such as a sealing flange 154. With reference between FIGS. 2Aand 5, the base 152 is generally sized and shaped for assembly to thegenerator body 30, for example via a perimeter shape including a shapeof the flange 50. The base 152 forms a pair of apertures 156 sized to bereceived over respective ones of the fluid circuit tubular bodies 90.The nasal prongs 150 a, 150 b may be of any size and shape as aresuitable for interacting with the patient's nares, and are fluidly opento the apertures 154. Assembly of the patient interface piece 32 to thegenerator body 30 generally entails establishing a fluid connectionbetween the nasal prongs 150 a, 150 b, and the patient side 76 of arespective one of the flow circuits 44 a, 44 b. In other embodiments,the patient interface 32 can be a nasal mask.

Another generator body 200 in accordance with principles of the presentdisclosure and useful with the nCPAP system 20 (FIG. 1) is shown inFIGS. 6A and 6B. As with the generator body 30, the generator body 200forms or defines a gas supply inlet 202, a chamber 204, and first andsecond flow circuits 206 a, 206 b (one of which is more clearly visiblein the view of FIG. 6B). The supply inlet 202 and the chamber 204 areakin to the inlet 40 (FIG. 2A) and the chamber 42 (FIG. 2B) describedabove, with the chamber 204 fluidly connecting the supply inlet 202 withthe flow circuits 206 a, 206 b. The flow circuits 206 a, 206 b eachinclude a nozzle 210, a channel 212, and at least two open ports 214.The nozzle 210 is configured to convert gas flow from the chamber 204into a jet stream directed to the channel 212. The channel 212 extendsfrom the nozzle 210, and terminates at a patient side 216. The openports 214 are akin to the open port 74 (FIG. 2C) described above, andare generally configured to facilitate exhaust of gas during anexpiratory phase of operation and entrainment of ambient air (ifnecessary) during an inspiratory phase.

For example, as shown in FIG. 6B, the first flow circuit 206 a includesa first or primary port 214 a and a second or secondary port 214 b. Theprimary port 214 a is open to the channel 212 at an interior aperture220 and is open to ambient via an exterior aperture 222 in the generatorbody 200. The secondary port 214 b is similarly open to the channel 212at an interior aperture 224 and to ambient air via an exterior aperture226 formed in a tubular body 228 of the channel 212. More particularly,the secondary port exterior aperture 222 is fluidly open to a secondarychamber 230 defined between inner and outer housing sections 232, 234,with the secondary chamber 230, in turn, being open to ambient via apassageway 236 through the generator body 200.

A relationship of the ports 214 a, 214 b is more clearly evidenced bythe cross-sectional view of FIG. 7. As a point of reference, FIG. 7represents an alternative generator body 200′ that is highly akin to thegenerator body 200 of FIGS. 6A and 6B. With the construction of FIG. 7,however, the gas supply inlet 202 is arranged parallel with the channel212 (as compared to the more perpendicular arrangement of FIGS. 6A and6B). Further, the secondary port 214 b is shown as being directly opento ambient at the exterior aperture 226 (i.e., the secondary chamber 230and the passageway 236 of FIG. 6B are omitted), with the secondary portexterior aperture 222 being formed in or at an exterior of the generatorbody 200′. From a functional standpoint, however, the generator bodies200, 200′ are identical.

The primary port 214 a is formed through a thickness of the generatorbody 200′, and is generally defined by a leading end wall 240 and atrailing end wall 242 (relative to the longitudinal cross-sectional viewof FIG. 7). As shown, the leading end wall 240 is proximate the nozzle210 (as compared to the trailing end wall 242), and projects radiallyoutwardly in extension from the channel 212. Stated otherwise, theleading end wall 240 tapers inwardly from the exterior aperture 222 tothe interior aperture 220. Thus, relative to a centerline C of thechannel 212, extension of the leading end wall 240 defines an includedangle a of less than 90°. The trailing end wall 242 can extend betweenthe apertures 220, 222 in a more perpendicular fashion relative to thecenterline C. With this construction, the primary port 214 a optionallyhas an expanding cross-sectional area in extension from the channel 212to the exterior aperture 222 (i.e., a size of the primary port 214 a atthe interior aperture 220 is less than a size at the exterior aperture222).

The secondary port 214 b extends from the channel 212 at a locationgenerally opposite that of the primary port 214 a. For example, theprimary port 214 a is located at an upper wall surface 250 of thechannel 212, whereas the secondary port 214 b is located at a lower wallsurface 252. The secondary port 214 b can have the generally linearshape shown (in extension from the channel 212), and can be radiallyaligned with the primary port 214 a. For example, the secondary port 214b can be located such that an axis of the secondary port 214 b extendsthrough the primary port 214 a. In some embodiments, the channel 212forms a region of increasing diameter between the nozzle 210 and thesecondary port 214 b. In particular, an angled guide surface 254 can bedefined between a nozzle side 256 of the channel 212 and the secondaryport interior aperture 224. With this construction, the secondary port214 b, and in particular the secondary port interior aperture 224, is“below” a centerline or axis of the nozzle 210 for reasons made clearbelow.

The primary port 214 a is larger than the secondary port 214 b. Forexample, a cross-sectional area of the primary port 214 a at the primaryport interior aperture 220 is greater than a cross-sectional area of thesecondary port 214 b at the secondary port interior aperture 224.Further, a cross-sectional area of the primary port 214 a at the primaryport exterior aperture 222 is greater than a cross-sectional area of thesecondary port exterior aperture 226. Regardless, the primary port 214 afacilitates a greater volumetric gas flow as compared to the secondaryport 214 b.

The open ports 214 a, 214 b are located in highly close proximity to thenozzle 210. As reflected in FIG. 8A, the flow direction of a jet stream(illustrated by arrow N in FIG. 8A) from the nozzle 210 is generallyunaligned with the ports 214 a, 214 b such that in the absence of othercounteractive gas flows or pressures, the jet stream flow N from thenozzle 210 is primarily directed past the ports 214 a, 214 b and towardthe patient side of the channel 212.

During operation, pressurized gas (e.g., from the source of gas 26 (FIG.1)) is provided to the chamber 204 via the supply inlet 202. Thesupplied gas is forced into the flow circuits 206. The nozzle 210 ofeach flow circuit 206 converts the gas flow to the jet stream N that isdirected into the corresponding channel 212. During an inspiratory phaseof operation (i.e., patient inhaling) reflected in FIG. 8B, at least aportion of the jet stream N passes through the channel 212 and issupplied to the patient via the patient side 216. The jet stream Nmomentum delivers a continuous positive pressure to the patient side216. Depending upon the respiratory needs of the patient duringinhalation, ambient air is entrained into the delivered flow primarilyvia the primary port 214 a (represented by arrows A in FIG. 8B). Thus,when the patient's inspiratory demand exceeds the set flow rate of thejet stream N, the jet stream N is generated so as to enhance entrainmentof supplemental ambient air A for delivery to the patient side 216, andthus the patient. Further, and again depending upon the patient'srespiratory needs, excess gas can be exhausted from the channel 212primarily via the secondary port 214 b (identified by arrows E in FIG.8B). Thus, when the jet stream N flow rate exceeds the inspiratorydemand of the patient, excess gas is exhausted via the port(s) 214 a,214 b.

An expiratory phase of operation (i.e., patient exhaling) is reflectedin FIG. 8C. Once again, the gas jet stream N is delivered to the channel212 at a fixed rate, maintaining the continuous positive airway pressuredelivered to the patient by the jet stream's N momentum. Exhaled air(represented by arrows X in FIG. 8C) from the patient is delivered tothe channel 212 via the patient side 216 and acts upon the jet stream N(as well as any entrained ambient air A). Because the jet stream N flowhas a relatively low momentum, it is easily disrupted by the exhaled airX. Further, the secondary port 214 b presents a path of least resistancefor the exhaled air X. In particular, the secondary port 214 b islocated “below” the centerline of the jet stream N so that the exhaledair X is able to more easily flow “under” the jet stream N to thesecondary port 214 b. Also, the entrained ambient air A at the primaryport 214 b (in combination with the jet stream N) slightly increases aresistance to flow of the exhaled air X to the primary port 214 a. As aresult, the exhaled air X flows primarily to the secondary port 214 b,with this flow direction causing the jet stream N flow to divert or“turn” toward the primary port 214 a. Thus, a significant portion of thejet stream N readily exhausts from the channel 212. The open ports 214a, 214 b combine to establish flow patterns that minimize flowresistance to the exhaled air X and thus the corresponding patient'swork-of-breathing. The jet stream N, as well as the exhaled air X,readily exhaust from the generator body 200′ via the primary andsecondary ports 214 a, 214 b as shown.

Gas flow through the second flow circuit 206 b (FIG. 6B) occurs in avirtually identical manner to that described above with respect to thefirst flow circuit 206 a. In this regard, FIG. 9 represents a modelingof an internal or fluid volume of the generator body 200′ and reflectsthe first and second flow circuits 206 a, 206 b as each having thenozzle 210 fluidly connected to the chamber 204, as well as the primaryand secondary ports 214 a, 214 b facilitating entrainment and exhaust ofgas to/from the corresponding channel 212. By combining the relativelylarge diameter driving jet geometry with the primary and secondary ports214 a, 214 b, the generator body 200′ can facilitate targeted patientCPAP levels at relatively low supply gas pressures. Further, thesecondary exhaust port 214 b reduces fluctuation in the delivered CPAPpressure during both inhalation and exhalation such that thework-of-breathing required by a patient is kept very low. Thesebeneficial attributes of the generator body 200′ are described ingreater detail below.

The generator bodies of the present disclosure have surprisingly beenfound to beneficially reduce the supplied gas pressure (or “drivingpressure”) necessary to achieve a targeted CPAP level as compared toconventional designs. For example, FIG. 10 graphically illustrates testresults of driving pressure as a function of supplied CPAP for thegenerator bodies 30 (FIG. 2A), 200′ (FIG. 7), as well as two currentlyavailable CPAP generator bodies.

In particular, prototype CPAP generators were constructed in accordancewith FIGS. 2A and 7, and were subjected to testing by supplyingpressurized gas at varying levels to the generator body and recordingthe resulting level of produced CPAP. Test results for the generatorbody 30 of FIG. 2A are represented by the plot line 30A in FIG. 10; thetest results for the generator body 200′ of FIG. 7 are represented bythe plot line 200A in FIG. 10. For comparative purposes, an Infant Flow™CPAP generator (available from CareFusion, Inc.) and an AirLife™ CPAPgenerator (available from CareFusion, Inc.) were subjected to identicaltesting. The plot line IF in FIG. 10 represents the test results for theInfant Flow™ generator; the plot line AL reflects the test results forthe AirLife™ generator.

FIG. 10 reveals that a target patient CPAP level can be achieved withthe generator bodies of the present disclosure at a driving pressurethat is less than those required by existing devices. For example, atarget patient CPAP level of 5 cm H₂O may be achieved with a drivingpressure not greater than 18 cm H₂O with the generator bodies 30, 200′of the present disclosure; in contrast, existing CPAP generatorsgenerally require a driving pressure of greater than 75 cm H₂O toachieve a CPAP level of 5 cm H₂O. Similarly, a target patient CPAP levelof 20 cm H₂O can be achieved with the generator bodies 30, 200′ of thepresent disclosure with a driving pressure of not greater than 60 cmH₂O; by way of comparison, existing CPAP generators generally require adriving pressure of greater than 275 cm H₂O to achieve a CPAP level of20 cm H₂O. With the generator bodies of the present disclosure, then,the reduced driving pressure requirements can provide enhanced safety inthat the source of pressurized gas 26 (FIG. 1), that is otherwise inrelatively close proximity to the patient during use, operates at alower pressure as compared to conventional nCPAP systems. In fact, andunlike previous CPAP generators, the generator bodies of the presentdisclosure are capable of operating within the driving pressure limitsof common ventilators, thereby obviating the need for the caregiver tomaintain a separate source of pressurized gas (apart from a ventilatorthat is otherwise normally on-hand) to perform CPAP procedures.

In addition to reducing the necessary driving pressure to achieve targetCPAP levels, the generator bodies of the present disclosure havesurprisingly been found to reduce the total imposed work-of-breathing(WOB) of the patient. In particular, the flow directing feature (e.g.,the ramp regions 110, 112 of FIG. 2C) of the generator body 30 (FIG. 2A)and/or the optimized primary and secondary ambient ports (e.g., theports 214 a, 214 b of FIG. 7) associated with the generator bodies 200(FIG. 6A), 200′ (FIG. 7) enable the CPAP-generating jet stream tooptimally self-adjust thereby keeping pressure fluctuations beneficiallylow (as compared to currently available CPAP generators) in turnlowering the total imposed WOB.

Total imposed WOB testing was performed on the prototype generatorbodies 30, 200′, the Infant Flow™ generator, and the AirLife™ generatorsamples used with the driving pressure tests described above byconnecting the samples to an industry-accepted lung simulator (IngMarMedical ASL 5000 Breathing Simulator utilizing Software Version 2.2.22aand available from IngMar Medical, Ltd., of Pittsburgh, Pa.). Totalimposed WOB was measured and recorded at several simulated patient tidalvolumes for each generator at a CPAP setting of 5 cm H₂O. The totalimposed WOB test results are shown in FIG. 11. The results for thegenerator body 30 are plotted by the line 30B in FIG. 11; the testresults for the generator body 200′ are plotted by the line 200B. By wayof comparison, the total imposed WOB test results for the availableInfant Flow™ CPAP generator are plotted by the line IF, whereas the testresults for the available AirLife™ CPAP generator are plotted by theline AL. As shown, the total imposed WOB for a 9 mL patient tidal volumeis not greater than 80 mJ/L using the generator bodies of the presentdisclosure. In contrast, the total imposed WOB for a 9 mL patient tidalvolume is greater than 115 mJ/L with currently available CPAP generators(that otherwise require the comparatively higher driving pressures asdescribed above). Similarly, the total imposed WOB for a 24 mL patienttidal volume is not greater than 130 mJ/L with the generator bodies ofthe present disclosure; in contrast, the total imposed WOB requirementsat a 24 mL patient tidal volume is greater than 140 mJ/L with currentlyavailable CPAP generators (that require comparatively higher drivingpressures). As used throughout this specification, a total imposed WOBparameter of a generator body is determined by testing with theabove-identified. IngMar Medical ASL 5000 Breathing Simulator.

The CPAP devices, and related systems and methods, of the presentdisclosure provide a marked improvement over previous designs. Inparticular, the generator bodies envisioned by the present disclosurehave reduced driving pressure requirements necessary for deliveringdesired levels of CPAP, as well as reduced total imposed WOB properties.Further, by incorporating low profile ports and condensed jet streamfeatures, the generator bodies of the present disclosure can berelatively small as compared to existing designs.

Although the present disclosure has been described with reference topreferred embodiments, workers skilled in the art will recognize thatchanges can be made in form and detail without departing from the spiritand scope of the present disclosure.

1-50. (canceled)
 51. A nasal continuous positive airway pressure devicefor use in a CPAP system to assist patient breathing, the devicecomprising: a generator body forming: a gas supply inlet for fluidconnection to a source of pressurized gas; a chamber fluidly connectedto the gas supply inlet; and first and second flow circuits fluidlyconnected to the chamber, each of the flow circuits including: a nozzledefining an inlet end and an outlet end, the inlet end fluidly connectedto the chamber; a channel comprising a tubular body having a nozzle sidefluidly connected to the outlet end of the nozzle and a patient sideopposite the nozzle side for directing gas to and from a patient'snaris; a first port fluidly connected to the channel at a first interioraperture and connected to ambient air via a first exterior aperture inthe generator body; and a second port fluidly connected to the channelat a second interior aperture and connected to the ambient air via asecond exterior aperture, wherein the nozzle is configured to create ajet stream from pressurized gas in the chamber, the jet stream beingdeliverable to the channel and divertible to the first and second ports.52. The device of claim 51, further comprising a patient interface piecefluidly coupled to the patient side of the channels.
 53. The device ofclaim 51, wherein the gas supply inlet is arranged perpendicularly tothe channel.
 54. The device of claim 53, wherein the second exterioraperture is in the tubular body of the channel, the second exterioraperture is fluidly connected to a second chamber defined between innerand outer housing sections of the generator body, and the second chamberis fluidly connected to ambient air via a passageway through thegenerator body.
 55. The device of claim 51, wherein the gas supply inletis arranged parallel to the channel.
 56. The device of claim 55, whereinthe second port is fluidly connected directly to the ambient air via thesecond exterior aperture formed in the generator body.
 57. The device ofclaim 51, wherein in longitudinal cross-section, the channel of each ofthe flow circuits is defined by a lower wall surface opposite an upperwall surface, the corresponding first port being formed in the upperwall surface and the corresponding second port being formed in the lowerwall surface.
 58. The device of claim 57, wherein the first port isdefined by a leading end wall proximate the nozzle and a trailing endwall proximate the channel, wherein the leading end wall tapers inwardlyfrom the exterior aperture to the interior aperture, wherein thetrailing end wall extends between the interior and exterior apertures,and wherein the first port has an expanding cross-sectional area fromthe channel to the first exterior aperture.
 59. The device of claim 57,further comprising an angled guide surface defined between the nozzleside of the channel and the second interior aperture, wherein thechannel has an increasing diameter between the nozzle and the secondport.
 60. The device of claim 57, wherein a cross-sectional area of thefirst port at the first interior aperture is greater than across-sectional area of the second port at the second interior apertureand a cross-sectional area of the first port at the first exterioraperture is greater than a cross-sectional area of the second exterioraperture, and wherein the first port is configured to facilitate agreater volumetric gas flow than the second port.
 61. The device ofclaim 51, wherein the generator body is configured to establish: aninspiratory flow pattern during an inspiratory stage of breathing, theinspiratory flow pattern including gas flow from the chamber, along eachof the first and second flow circuits, and to the patient side of eachof the channels; and an expiratory flow pattern during an expiratorystage of breathing, the expiratory flow pattern including gas flow fromthe patient side of each of the channels primarily to the correspondingsecond ports, and including diversion of the jet stream to thecorresponding first ports.
 62. The device of claim 61, wherein gas flowdirected toward the nozzle as part of the expiratory flow patterndiverts the jet stream to the first port.
 63. A nasal continuouspositive airway pressure system for assisting patient breathing, thesystem comprising: a generator body forming: a gas supply inlet; achamber fluidly connected to the gas supply inlet; first and second flowcircuits fluidly connected to the chamber, each of the flow circuitsincluding: a nozzle defining an inlet end and an outlet end, the inletend fluidly connected to the chamber; a channel having a nozzle sidefluidly connected to the outlet end of the nozzle and a patient sideopposite the nozzle side for directing gas to and from a patient'snaris; a first port fluidly connected to the channel at a first interioraperture and connected to ambient air via a first exterior aperture inthe generator body; and a second port fluidly connected to the channelat a second interior aperture and connected to ambient air via a secondexterior aperture; a patient interface piece fluidly connected to thepatient side of the channels, respectively; and a source of pressurizedgas fluidly connected to the gas supply inlet, wherein upon securementof the patient interface piece to a patient's nares, the system isconfigured to generate a continuous positive airway pressure in thepatient by delivering gas from the source of pressurized gas to thenozzles that in turn emits a gas jet stream within the correspondingchannel in a direction of the patient interface piece.
 64. The system ofclaim 63, wherein the gas supply inlet is arranged perpendicularly tothe channel, wherein the second exterior aperture is in a body of thechannel, wherein the second exterior aperture is fluidly connected to asecond chamber defined between inner and outer housing sections of thegenerator body, and wherein the second chamber is fluidly connected toambient air via a passageway through the generator body.
 65. The systemof claim 63, wherein the gas supply inlet is arranged parallel to thechannel, and wherein the second port is fluidly connected directly tothe ambient air via the second exterior aperture formed in the generatorbody.
 66. The system of claim 63, wherein in longitudinal cross-section,the channel of each of the flow circuits is defined by a lower wallsurface opposite an upper wall surface, the corresponding first portbeing formed in the upper wall surface and the corresponding second portbeing formed in the lower wall surface.
 67. The system of claim 66,wherein the first port is defined by a leading end wall proximate thenozzle and a trailing end wall proximate the channel, wherein theleading end wall tapers inwardly from the exterior aperture to theinterior aperture, wherein the trailing end wall extends between theinterior and exterior apertures, and wherein the first port has anexpanding cross-sectional area from the channel to the first exterioraperture.
 68. The system of claim 66, further comprising an angled guidesurface defined between the nozzle side of the channel and the secondinterior aperture, wherein the channel has an increasing diameterbetween the nozzle and the second port.
 69. The system of claim 66,wherein a cross-sectional area of the first port at the first interioraperture is greater than a cross-sectional area of the second port atthe second interior aperture and a cross-sectional area of the firstport at the first exterior aperture is greater than a cross-sectionalarea of the second exterior aperture, and wherein the first port isconfigured to facilitate a greater volumetric gas flow than the secondport.
 70. The system of claim 63, wherein the generator body isconfigured to establish: an inspiratory flow pattern during aninspiratory stage of breathing, the inspiratory flow pattern includinggas flow from the chamber, along each of the first and second flowcircuits, and to the patient side of each of the channels; and anexpiratory flow pattern during an expiratory stage of breathing, theexpiratory flow pattern including gas flow from the patient side of eachof the channels primarily to the corresponding second ports, andincluding diversion of the jet stream to the corresponding first portsby the gas flow from the patient side.